Clinical trial of the effect of combined magnesium and vitamin E supplementation compared with the placebo on metabolic profiles in patients with diabetic foot ulcer
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Protocol summary
Objective: The aim of this study is to determine the effects of combined magnesium and vitamin E supplementation on metabolic profiles in patients with diabetic foot ulcer. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with diabetic foot ulcer and aged 40 to 85 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 60 patients with diabetic foot ulcer of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences in the study will be selected. Intervention: Patients will be assigned into two groups to receive combined magnesium and vitamin E supplements (n=30) or placebo (n=30). Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 12 weeks. Outcomes: Markers of insulin metabolism (primary outcomes), lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcomes) will be quantified at study baseline and end-of-trial.
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Objective: The aim of this study is to determine the effects of combined magnesium and vitamin E supplementation on metabolic profiles in patients with diabetic foot ulcer. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with diabetic foot ulcer and aged 40 to 85 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 60 patients with diabetic foot ulcer of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences in the study will be selected. Intervention: Patients will be assigned into two groups to receive combined magnesium and vitamin E supplements (n=30) or placebo (n=30). Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 12 weeks. Outcomes: Markers of insulin metabolism (primary outcomes), lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcomes) will be quantified at study baseline and end-of-trial.
هدف: هدف این مطالعه تعیین اثرات مکمل یاری ترکیب منیزیم و ویتامین E بر پروفایل های متابولیک در بیماران مبتلا به زخم پای دیابتی است. طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: بیماران مبتلا به زخم پای دیابتی در محدوده سنی 40 تا 85 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به زخم پای دیابتی واجد شرایط و ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران به دو گروه برای دریافت مکمل یاری ترکیب ویتامین E و منیزیم (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد. کپسول های مکمل و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته. پيامدها: مارکرهای متابولیسم انسولین (پیامدهای اولیه) و پروفایل های لیپیدی، بیومارکرهای التهاب و استرس اکسیداتیو (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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هدف: هدف این مطالعه تعیین اثرات مکمل یاری ترکیب منیزیم و ویتامین E بر پروفایل های متابولیک در بیماران مبتلا به زخم پای دیابتی است. طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی. تصادفی سازی با استفاده ازجدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. معیار ورود به مطالعه: بیماران مبتلا به زخم پای دیابتی در محدوده سنی 40 تا 85 سال وارد مطالعه خواهند شد. معیار خروج از مطالعه: عدم تمایل به همکاری. حجم نمونه و جمعیت مورد مطالعه: 60 بیمار مبتلا به زخم پای دیابتی واجد شرایط و ارجاع شده به کلینیک نقوی وابسته به دانشگاه علوم پزشکی کاشان در مطالعه انتخاب خواهند شد. مداخله مورد مطالعه: بیماران به دو گروه برای دریافت مکمل یاری ترکیب ویتامین E و منیزیم (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد. کپسول های مکمل و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته. پيامدها: مارکرهای متابولیسم انسولین (پیامدهای اولیه) و پروفایل های لیپیدی، بیومارکرهای التهاب و استرس اکسیداتیو (پیامدهای ثانویه) در ابتدا و انتهای مداخله اندازه گیری خواهد شد.
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The aim of this study is to determine the effects of combined magnesium and vitamin E supplementation on metabolic profiles in patients with diabetic foot ulcer.
The aim of this study is to determine the effects of combined magnesium and vitamin E supplementation on metabolic profiles in patients with diabetic foot ulcer.
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هدف این مطالعه تعیین اثرات مکمل یاری ترکیب منیزیم و ویتامین E بر پروفایل های متابولیک در بیماران مبتلا به زخم پای دیابتی است.
هدف این مطالعه تعیین اثرات مکمل یاری ترکیب منیزیم و ویتامین E بر پروفایل های متابولیک در بیماران مبتلا به زخم پای دیابتی است.
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Parallel double-blind (both patients and researchers) randomized controlled clinical trial
Parallel double-blind (both patients and researchers) randomized controlled clinical trial
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کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی
کارآزمایی بالینی دو سوکور (هم بیماران و هم محققان) موازی
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Sixty patients with diabetic foot ulcer of eligible and referred to Shahid Beheshti Clinic affiliated to Kashan University of Medical Sciences in the study will be selected.
Sixty patients with diabetic foot ulcer of eligible and referred to Shahid Beheshti Clinic affiliated to Kashan University of Medical Sciences in the study will be selected.
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شصت بیمار مبتلا به زخم پای دیابتی واجد شرایط و ارجاع شده به کلینیک شهید بهشتی وابسته به دانشگاه علوم پزشکی کاشان در مطالعه انتخاب خواهند شد.
شصت بیمار مبتلا به زخم پای دیابتی واجد شرایط و ارجاع شده به کلینیک شهید بهشتی وابسته به دانشگاه علوم پزشکی کاشان در مطالعه انتخاب خواهند شد.
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Patients with diabetic foot ulcer and aged 40 to 85 years will be included in this study. Pregnant and breastfed patients, participants who consumed magnesium, vitamin E or other antioxidative supplements during past 3 months, taking antiinflammatory agents, change in consuming medications throughout the study and patients with history of diseases which influence the development of DFU including chronic trauma, will excluded.
Patients with diabetic foot ulcer and aged 40 to 85 years will be included in this study. Pregnant and breastfed patients, participants who consumed magnesium, vitamin E or other antioxidative supplements during past 3 months, taking antiinflammatory agents, change in consuming medications throughout the study and patients with history of diseases which influence the development of DFU including chronic trauma, will excluded.
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بیماران مبتلا به زخم پای دیابتی در محدوده سنی 40 تا 85 سال وارد مطالعه خواهند شد. بیماران باردار و شیرده ، شرکت کننده هایی که در طول سه ماه گذشته منیزیم ، ویتامین E یا سایر مکمل های آنتی اکسیدانی مصرف کرده اند، مصرف داروهای ضد التهابی ، تغییر در مصرف داروها در طول مطالعه و بیماران دارای سابقه بیماری هایی که بر توسعه DFU از جمله ترومای مزمن تأثیر می گذارد ، از مطالعه حذف می شوند.
بیماران مبتلا به زخم پای دیابتی در محدوده سنی 40 تا 85 سال وارد مطالعه خواهند شد. بیماران باردار و شیرده ، شرکت کننده هایی که در طول سه ماه گذشته منیزیم ، ویتامین E یا سایر مکمل های آنتی اکسیدانی مصرف کرده اند، مصرف داروهای ضد التهابی ، تغییر در مصرف داروها در طول مطالعه و بیماران دارای سابقه بیماری هایی که بر توسعه DFU از جمله ترومای مزمن تأثیر می گذارد ، از مطالعه حذف می شوند.
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Patients will be assigned into two groups to receive combined magnesium and vitamin E supplements (n=30) or placebo (n=30).
Patients will be assigned into two groups to receive combined magnesium and vitamin E supplements (n=30) or placebo (n=30).
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بیماران به دو گروه برای دریافت مکمل یاری ترکیب ویتامین E و منیزیم (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد.
بیماران به دو گروه برای دریافت مکمل یاری ترکیب ویتامین E و منیزیم (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد.
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Fasting plasma glucose, lipid profiles, inflammatory factors, oxidative stress, and mean ulcer area
Fasting plasma glucose, lipid profiles, inflammatory factors, oxidative stress, and mean ulcer area
Patients with grade 3 diabetic foot ulcer
Aged 40 to 85
Patients with grade 3 diabetic foot ulcer Aged 40 to 85
بیماران مبتلا به زخم پای دیابتی گرید 3
سنین 40 تا 85 سال
بیماران مبتلا به زخم پای دیابتی گرید 3 سنین 40 تا 85 سال
Pregnant and breastfed patients
Participants who consumed magnesium, vitamin E or other antioxidative supplements during past 3 months
Taking anti-inflammatory agents
Change in consuming medications throughout the study
Patients with history of diseases which influence the development of diabetic foot ulcer including chronic trauma
Pregnant and breastfed patients Participants who consumed magnesium, vitamin E or other antioxidative supplements during past 3 months Taking anti-inflammatory agents Change in consuming medications throughout the study Patients with history of diseases which influence the development of diabetic foot ulcer including chronic trauma
بیماران باردار و شیرده
شرکت کنندگانی که در طول 3 ماه گذشته منیزیم، ویتامین ای یا سایر مکمل های آنتی اکسیدانی
دریافت داروهای ضدالتهابی
تغییر در مصرف داروها در طول مطالعه
بیماران با سابقه بیماری هایی که در ایجاد زخم پای دیابتی از جمله ترومای مزمن تأثیر می گذارد
بیماران باردار و شیرده شرکت کنندگانی که در طول 3 ماه گذشته منیزیم، ویتامین ای یا سایر مکمل های آنتی اکسیدانی دریافت داروهای ضدالتهابی تغییر در مصرف داروها در طول مطالعه بیماران با سابقه بیماری هایی که در ایجاد زخم پای دیابتی از جمله ترومای مزمن تأثیر می گذارد
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At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either combined magnesium and vitamin E supplements (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers.
At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either combined magnesium and vitamin E supplements (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers.
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در ابتدای مطالعه و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و سن، افراد به طور تصادفی به دو گروه برای دریافت مکمل ترکیب منیزیم و ویتامین E (n = 30) و پلاسبو (n = 30) تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
در ابتدای مطالعه و بعد از طبقه بندی بر اساس مقادیر پایه نمایه توده بدنی و سن، افراد به طور تصادفی به دو گروه برای دریافت مکمل ترکیب منیزیم و ویتامین E (n = 30) و پلاسبو (n = 30) تخصیص داده می شوند. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد.
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Shahid Beheshti clinic, Kashan who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Shahid Beheshti clinic, Kashan who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک شهید بهشتی، کاشان که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد.
تصادفی سازی و تخصیص تصادفی از محققان و شرکت کنندگان در مطالعه تا زمان تکمیل آنالیز آماری پنهان خواهد ماند. فرد دیگری در کلینیک شهید بهشتی، کاشان که در این کارآزمایی بالینی نقشی ندارد و از تخصیص تصادفی آگاه نیست، به شرکت کنندگان در مطالعه، بطری های شماره گذاری شده کپسول ها را تخصیص خواهد داد.
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Primary outcomes
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Healing of diabetic foot ulcer
Healing of diabetic foot ulcer
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بهبود زخم پای دیابتی
بهبود زخم پای دیابتی
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At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Decrease of the wound size relative to original size: ulcer length (cm), ulcer width (cm), Ulcer depth (cm)
Decrease of the wound size relative to original size: ulcer length (cm), ulcer width (cm), Ulcer depth (cm)
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کاهش اندازه زخم نسبت به اندازه اصلی: طول زخم (سانتی متر) ، عرض زخم (سانتی متر) ، عمق زخم (سانتی متر)
کاهش اندازه زخم نسبت به اندازه اصلی: طول زخم (سانتی متر) ، عرض زخم (سانتی متر) ، عمق زخم (سانتی متر)
Secondary outcomes
#1
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LDL
LDL
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LDL
LDL
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At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Enzymatic kit
Enzymatic kit
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کیت آنزیمی
کیت آنزیمی
#2
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Fasting plasma glucose
Fasting plasma glucose
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گلوکز پلاسمایی ناشتا
گلوکز پلاسمایی ناشتا
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At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Enzymatic kit
Enzymatic kit
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کیت آنزیمی
کیت آنزیمی
#3
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HbA1c
HbA1c
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HbA1c
HbA1c
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At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Biochemical kit
Biochemical kit
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کیت بیوشیمیایی
کیت بیوشیمیایی
#4
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Magnesium
Magnesium
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منیزیم
منیزیم
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At the beginning of the study and after 12 weeks of intervention
At the beginning of the study and after 12 weeks of intervention
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در ابتدای مطالعه و 12 هفته بعد از مداخله
در ابتدای مطالعه و 12 هفته بعد از مداخله
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Enzymatic kit
Enzymatic kit
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کیت آنزیمی
کیت آنزیمی
Recruitment centers
#1
Name of recruitment center - English: Naghavi Clinic
Name of recruitment center - Persian: کلینیک نقوی
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: Shahid Rajaee Avenue, Kashan
Street address - Persian: کاشان، خیابان شهید رجایی
City - English: Kashan
City - Persian: کاشان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Shahid Beheshti Clinic
Name of recruitment center - Persian: کلینیک شهید بهشتی
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5562 0608
Fax:
Email: asemi_z@kaums.ac.ir
Web page address:
Name of recruitment center - English: NaghaviShahid Beheshti Clinic Name of recruitment center - Persian: کلینیک نقویشهید بهشتی Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Street address - English: Shahid Rajaee AvenueGhotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، خیابان شهید رجاییبلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5562 0608 Fax: Email: asemi_z@kaums.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Gholamali Hamidi
Full name of responsible person - Persian: غلامعلی حمیدی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Gholamali Hamidi
Full name of responsible person - Persian: غلامعلی حمیدی
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5554 2999
Fax:
Email: research@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, Kashan University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Gholamali Hamidi Full name of responsible person - Persian: غلامعلی حمیدی Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5554 2999 Fax: Email: research@kaums.ac.ir Web page address:
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Public
public
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Domestic
domestic
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Academic
academic
Vice chancellor for research, Kashan University of Medical Sciences
Kashan University of Medical Sciences
Vice chancellor for research, Kashan University of Medical Sciences
معاونت پژوهشی دانشگاه علوم پزشکی کاشان
دانشگاه علوم پزشکی کاشان
معاونت پژوهشی دانشگاه علوم پزشکی کاشان
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشكي كاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: Ph.D of Nutrition
Position - Persian: دکترای تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: Ph.D of Nutrition
Position - Persian: دکترای تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Kashan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشكي كاشان Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: Ph.D of Nutrition Position - Persian: دکترای تغذیه Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: Ph.D of Nutrition
Position - Persian: دکترای تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: Ph.D of Nutrition
Position - Persian: دکترای تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Kashan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: Ph.D of Nutrition Position - Persian: دکترای تغذیه Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Kashan University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: Ph.D of Nutrition
Position - Persian: دکترای تغذیه
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Zatollah Asemi
Full name of responsible person - Persian: ذات اله عاصمی
Position - English: Ph.D of Nutrition
Position - Persian: دکترای تغذیه
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 81151-87159
Phone: +98 31 5546 3378
Mobile: +98 913 361 5446
Fax:
Email: asemi_z@kaums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Kashan University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی کاشان Full name of responsible person - English: Zatollah Asemi Full name of responsible person - Persian: ذات اله عاصمی Position - English: Ph.D of Nutrition Position - Persian: دکترای تغذیه Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 81151-87159 Phone: +98 31 5546 3378 Mobile: +98 913 361 5446 Fax: Email: asemi_z@kaums.ac.ir; asemi_r@yahoo.com Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
Undecided - It is not yet known if there will be a plan to make this available
Undecided - It is not yet known if there will be a plan to make this available
empty
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
هنوز تصمیم نگرفتهام - برنامه انتشار آن هنوز مشخص نیست
Protocol summary
Study aim
The aim of this study is to determine the effects of combined magnesium and vitamin E supplementation on metabolic profiles in patients with diabetic foot ulcer.
Design
Parallel double-blind (both patients and researchers) randomized controlled clinical trial
Settings and conduct
Sixty patients with diabetic foot ulcer of eligible and referred to Shahid Beheshti Clinic affiliated to Kashan University of Medical Sciences in the study will be selected.
Participants/Inclusion and exclusion criteria
Patients with diabetic foot ulcer and aged 40 to 85 years will be included in this study. Pregnant and breastfed patients, participants who consumed magnesium, vitamin E or other antioxidative supplements during past 3 months, taking antiinflammatory agents, change in consuming medications throughout the study and patients with history of diseases which influence the development of DFU including chronic trauma, will excluded.
Intervention groups
Patients will be assigned into two groups to receive combined magnesium and vitamin E supplements (n=30) or placebo (n=30).
Main outcome variables
Fasting plasma glucose, lipid profiles, inflammatory factors, oxidative stress, and mean ulcer area
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2017090533941N21
Registration date:2017-11-16, 1396/08/25
Registration timing:retrospective
Last update:2019-09-23, 1398/07/01
Update count:1
Registration date
2017-11-16, 1396/08/25
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2017-10-20, 1396/07/28
Expected recruitment end date
2017-11-05, 1396/08/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of combined magnesium and vitamin E supplementation compared with the placebo on metabolic profiles in patients with diabetic foot ulcer
Public title
Effect of combined magnesium and vitamin E supplementation in treatment of diabetic foot ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with grade 3 diabetic foot ulcer
Aged 40 to 85
Exclusion criteria:
Pregnant and breastfed patients
Participants who consumed magnesium, vitamin E or other antioxidative supplements during past 3 months
Taking anti-inflammatory agents
Change in consuming medications throughout the study
Patients with history of diseases which influence the development of diabetic foot ulcer including chronic trauma
Age
From 40 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either combined magnesium and vitamin E supplements (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Shahid Beheshti clinic, Kashan who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2017-10-19, 1396/07/27
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1396.65
Health conditions studied
1
Description of health condition studied
Diabetic foot ulcer
ICD-10 code
E14.5
ICD-10 code description
Non-insulin-dependent diabetes mellitus and with peripheral circulatory complications
Primary outcomes
1
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
2
Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using HOMA formula
3
Description
Healing of diabetic foot ulcer
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Decrease of the wound size relative to original size: ulcer length (cm), ulcer width (cm), Ulcer depth (cm)
Secondary outcomes
1
Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
2
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
4
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
5
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
6
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
7
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
8
Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
9
Description
LDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
10
Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
11
Description
HbA1c
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Biochemical kit
12
Description
Magnesium
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
Intervention groups
1
Description
Intervention group: 250 mg magnesium (21st Century, Arizona, USA) and 400 IU vitamin E (Zahravi, Tabriz, Iran) daily for 12 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo capsule (Barij Essence, Kashan, Iran), daily for 12 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Clinic
Full name of responsible person
Zatollah Asemi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5562 0608
Email
asemi_z@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 2999
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Ph.D of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Ph.D of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Ph.D of Nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available